Vocinti

See Table 1.


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Each tablet contains 10 mg of vonoprazan (13.36 mg of vonoprazan fumarate) and 20 mg of vonoprazan (26.72 mg of vonoprazan fumarate).
Vonoprazan Fumarate occurs as a white to practically white crystals or crystalline powder. It is soluble in dimethylsulfoxide, sparingly soluble in N,N-dimethylacetamide, slightly soluble in methanol and water and practically insoluble in 2-propanol and acetonitrile.
Nonproprietary name: Vonoprazan Fumarate [JAN].
Chemical name: 1-[5-(2-Fluorophenyl)-l-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanaminemonofumarate.
Molecular formula: C₁₇H₁₆FN₃O₂S·C₄H₄O₄.
Molecular weight: 461.46.
Melting point: 194.8°C.
Excipients/Inactive Ingredients: D-Mannitol, Crystalline Cellulose, Croscarmellose Sodium, Hydroxypropyl Cellulose, Fumaric Acid, Magnesium Stearate, Hypromellose, Macrogol 6000, Titanium Oxide (contained in all products), Yellow Ferric Oxide (contained in VOCINTI 10 mg Tablet only), Iron Sesquioxide (contained in VOCINTI 20 mg Tablet only).

Pharmacology: Pharmacodynamics: Mechanism of Action: Vonoprazan is a potassium competitive acid blocker (PCAB) and inhibits H⁺, K⁺-ATPase in a reversible and potassium-competitive manner. It does not require activation by acid. Vonoprazan has a strong basicity and resides on the acid production site of gastric parietal cells for a long time, thereby inhibiting gastric acid production. Vonoprazan exerts a strong inhibitory effect on formation of mucosal damage in the upper part of the gastrointestinal tract. Vonoprazan does not exhibit anti-Helicobacter pylori activity nor inhibitory activity against Helicobacter pylori urease.
Serum Gastrin and Serum Pepsinogen Effects: Increased serum gastrin and serum pepsinogen concentrations are physiological responses to treatment with acid suppression therapy, including vonoprazan. Increased serum gastrin and serum pepsinogen concentrations were reported with a higher incidence in the vonoprazan treatment groups compared with lansoprazole treatment groups. Serum gastrin and serum pepsinogen concentrations returned to baseline over time upon discontinuation of vonoprazan. The increase in serum gastrin concentration occurred early in treatment with vonoprazan and remained stable for the remainder of treatment.
Inhibiting activity on gastric acid secretion: Following consecutive administration of vonoprazan at a dose of 10 mg or 20 mg in healthy adult male subjects for 7 days, proportions of the time exhibiting gastric pH of 4 or above within 24 hours were 63±9% and 83±17%, respectively.
Adjunctive effect on eradication of Helicobacter pylori: The role of vonoprazan in the Helicobacter pylori eradication is considered to increase intragastric pH leading to the enhancement of antibacterial activity of amoxicillin hydrate, clarithromycin and metronidazole which are concomitantly administered.
Clinical Studies: Clinical efficacy: (1) Gastric ulcer, duodenal ulcer: The following table shows the overall healing rate by disease category of patients with gastric ulcer and duodenal ulcer who received a once daily oral dose of 20 mg of vonoprazan or 30 mg of lansoprazole for up to 8 weeks (in the case of gastric ulcer) and 6 weeks (in the case of duodenal ulcer) in double-blind comparative controlled studies. From the study conducted in patients with gastric ulcer, the non-inferiority was verified in the vonoprazan group compared to the lansoprazole group, however, the non-inferiority was not verified in the vonoprazan group compared to the lansoprazole group in the study in patients with duodenal ulcer. (See Tables 2 and 3.)


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(2) Reflux esophagitis: The following table shows the overall healing rate until 4 and 8 weeks after administration in patients with reflux esophagitis who received a once daily oral dose of 20 mg of vonoprazan or 30 mg of lansoprazole for up to 8 weeks in double-blind comparative controlled study. The non-inferiority was verified in the vonoprazan group compared to the lansoprazole group for the healing rate up to 8 weeks after administration. In addition, the point estimate (two-sided 95% confidence interval) of a difference between the healing rate until 4 weeks after administration in the vonoprazan group and the healing rate until 8weeks after administration in the lansoprazole group was 1.1% (-2.702 to 4.918%). (See Tables 4 and 5.)


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(3) Maintenance therapy of reflux esophagitis: 1) The recurrence rate observed in the single-blind long-term study in which a daily dose of 10 mg or 20 mg of vonoprazan was administered once daily for 52 weeks to the patients with confirmed healing of the reflux esophagitis and completed the study described in (2) above was 9.4% (14/149 cases) in the 10 mg group and 9.0% (13/145 cases) in the 20 mg group.
2) The following table shows the recurrence rate observed in the double-blind comparative controlled study in which a daily oral dose of 10 mg or 20 mg of vonoprazan or 15 mg of lansoprazole was administered once daily for 24 weeks in the maintenance of healing to patients with reflux esophagitis that was assessed as "healed" as the result of oral administration of a daily dose of 20 mg of vonoprazan once daily up to 8 weeks. The non-inferiority was verified in the vonoprazan 10 mg and 20 mg groups compared to the lansoprazole group. (See Table 6.)


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(4) Prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration: The following table shows the ulcer recurrence rate at 24 weeks after a once daily oral dose of 10 mg of vonoprazan or 15 mg of lansoprazole was administered once daily for 24 weeks to patients who required long-term low-dose aspirin administration (daily dose of 81 to 324 mg) and had a history of gastric ulcer or duodenal ulcer in double-blind comparative controlled study. The non-inferiority was verified in the vonoprazan group compared to the lansoprazole group. (See Table 7.)


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The following table shows the ulcer recurrence rate observed in the single-blind long-term study in which administration was continued for 28 weeks in minimum and for 80 weeks at maximum to the patients who completed the above study. (See Table 8.)


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(5) Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration: The following table shows the ulcer recurrence rate at 24 weeks after a once daily oral dose of 10 mg of vonoprazan or 15 mg of lansoprazole was administered once daily for 24 weeks to patients who required long-term administration of NSAIDs for pain management of rheumatoid arthritis or osteoarthritis, etc. and had a history of gastric ulcer or duodenal ulcer in double-blind comparative controlled study. The non-inferiority was verified in the vonoprazan group compared to the lansoprazole group. (See Table 9.)


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The following table shows the ulcer recurrence rate observed in the single-blind long-term study in which administration was continued for 28 weeks in minimum and for 80 weeks at maximum to the patients who completed the above study. (See Table 10.)


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(6) Helicobacter pylori infection in gastric ulcer or duodenal ulcer: The following table shows the eradication rates in Helicobacter pylori-positive gastric ulcer or duodenal ulcer scar patients who were administered with the following 3 drugs, i.e., 20 mg of vonoprazan or 30 mg of lansoprazole, amoxicillin hydrate, and clarithromycin, twice daily for 7 days in double-blind comparative controlled study. The non-inferiority was verified in triple therapy using vonoprazan compared to triple therapy using lansoprazole. (See Table 11.)


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In addition, the following table shows the eradication rates observed in the clinical trial in which 50 patients for whom Helicobacter pylori eradication with vonoprazan or lansoprazole, amoxicillin hydrate, and clarithromycin failed received oral administration of 20 mg/dose of vonoprazan, amoxicillin hydrate, and metronidazole twice daily for 7 days. (See Table 12.)


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Effects on serum gastrin and density of endocrine cells in gastric mucosa: (1) After a once daily oral administration of 10 mg or 20 mg of vonoprazan, serum gastrin levels were continuously higher in the vonoprazan group compared to the lansoprazole group. The changes in serum gastrin levels in a long-term clinical study for prevention of gastric ulcer or duodenal ulcer with administration of low dose aspirin is as shown as follows. The clinical trial in which patients with gastric ulcer and those with duodenal ulcer were evaluated for recovery of serum gastrin after the termination of administration observed the rapid recovery. (2 - 8 weeks after completion of administration.) (See Figure 1.)


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(2) When a once daily oral dose of 10 mg or 20 mg of vonoprazan was administered for 52 weeks in the maintenance of healing of reflux esophagitis, no obvious tendency toward an increase in the density of endocrine cells in gastric mucosa was observed.
Pharmacokinetics: Absorption: (a) Pharmacokinetics at single administration: Absolute bioavailability has not been determined. The pharmacokinetic parameters of vonoprazan following single administration of vonoprazan to healthy adult male subjects at 20 mg under fasting and fed conditions are presented in the following table (see Table 13 and Figure 2).


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(b) Pharmacokinetics at consecutive administration: At consecutive administration of a daily dose of 10 mg or 20 mg of vonoprazan in healthy adult male subjects once daily for 7 days, AUC_(0-tau) and C_max increase as the dose increases. The degree of these increases is slightly higher than the dose ratio. It is considered that the steady state has been reached by day 3 of administration, since the trough level of the blood concentration of vonoprazan is constant between day 3 and day 7 of administration. In addition, it is considered that pharmacokinetics of vonoprazan at consecutive administration may not be time-dependent, as the result of the evaluation of accumulation with regard to AUC_(0-tau) and T_½ of vonoprazan. The following table shows pharmacokinetic parameters of vonoprazan on day 7 of administration. (See Table 14.)


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Distribution: The mean binding rate is 85.2 to 88.0% when [¹⁴C] vonoprazan in the range of 0.1 to 10 μg/mL is added to human plasma (in vitro).
Metabolism: (1) Vonoprazan is metabolized mainly by hepatic drug-metabolizing enzyme CYP3A4 and partially by CYP2B6, CYP2C19 and CYP2D6. Vonoprazan is also metabolized by sulfotransferase SULT2A1 (in vitro).
(2) Vonoprazan exhibits time-dependent inhibitory effect on CYP2B6, CYP2C19 and CYP3A4/5 (in vitro). In addition, vonoprazan shows a slight concentration-dependent inductive effect on CYP1A2, but it shows little inductive effect on CYP2B6 and CYP3A4/5 (in vitro).
Excretion: When radioactive-labeled drug (15 mg as vonoprazan) is orally administered to non-Japanese healthy adult male subjects, 98.5% of the radioactivity administered is excreted into urine and feces by 168 hours after administration: 67.4% into urine and 31.1% into feces.
Impaired Renal Function: The effect of renal disorders on pharmacokinetics of vonoprazan in subjects with normal renal function, patients with mild, moderate, and severe renal disorder and patients with end-stage renal disease (ESRD) when administered the drug as vonoprazan 20 mg shows that AUC_(0-inf) and C_max were higher by 1.3 to 2.4 times and 1.2 to 1.8 times, respectively, in patients with mild, moderate, and severe renal disorder compared to subjects with normal renal function, showing an increase with a reduction in renal function. AUC_(0-inf) and C_max were higher by 1.3 times and 1.2 times, respectively, in ESRD patients compared to those in subjects with normal renal function.
Impaired Hepatic disorders: The effect of hepatic disorders on phannacokinetics in subjects with normal hepatic function and patients with mild, moderate, and severe hepatic disorder when administered the drug as vonoprazan 20 mg shows that AUC_(0-inf) and C_max were higher by 1.2 to 2.6 times and 1.2 to 1.8 times, respectively, in patients with mild, moderate, and severe hepatic disorder, compared to subjects with normal hepatic function.
Age, Gender, Race: Vonoprazan has not been studied in patients under 18 years of age. There are no clinically relevant gender effects of vonoprazan. No dedicated ethnic comparison studies have been conducted with vonoprazan. The ethnic sensitivity analysis based on the International Conference for Harmonization (ICH) E5 principles was conducted to assess whether the molecular properties of vonoprazan were sensitive to ethnic factor differences, and whether the diagnosis, medical practice, treatment options, and other epidemiological factors for acid-related disorders would vary dramatically in areas other than Japan. It was concluded that vonoprazan is insensitive to ethnic factor differences.
Drug Interactions: (1) Pharmacokinetics at concomitant administration of vonoprazan and clarithromycin: The drug interaction study in non-Japanese healthy adult male subjects administered with single dose of vonoprazan 40 mg 30 minutes after breakfast on day 1 and day 8, and with repeated dose of clarithromycin 500 mg (potency) 2 times daily 30 minutes before breakfast and dinner on day 3 - 9, shows that AUC_(0-inf) and C_max of vonoprazan when concomitantly administered with clarithromycin increased by 1.6 times and 1.4 times, respectively, compared to those of vonoprazan when administered alone.
(2) Pharmacokinetics at concomitant administration of vonoprazan, amoxicillin hydrate and clarithromycin: The drug interaction study in healthy adult male subjects administered with twice daily of vonoprazan 20 mg, amoxicillin hydrate 750 mg (potency) and clarithromycin 400 mg (potency) concomitantly for 7 days shows that no effect on pharmacokinetics of unchanged amoxicillin, however, AUC_(0-12) and C_max of vonoprazan increased by 1.8 times and 1.9 times, respectively, and AUC_(0-12) and C_max of unchanged clarithromycin increased by 1.5 times and 1.6 times, respectively.
(3) Vonoprazan, Bismuth, Clarithromycin and Amoxicillin: The drug interaction study in Helicobacter pylori positive adult subjects administered twice daily vonoprazan 20 mg or lansoprazole 30 mg with tripotassium bismuth dicitrate 600 mg, clarithromycin 500 mg, and amoxicillin 1000 mg concomitantly for 14 days shows the lack of a clinically meaningful effect of vonoprazan on the pharmacokinetics of bismuth compared with lansoprazole.
(4) Vonoprazan, amoxicillin hydrate and metronidazole: The drug interaction study in healthy adult male subjects administered twice daily with vonoprazan 20 mg, amoxicillin hydrate 750 mg (potency) and metronidazole 250 mg concomitantly for 7 days showed little difference in the pharmacokinetics of vonoprazan, when administered alone or as triple therapy. No difference was observed in the pharmacokinetics of metronidazole or amoxicillin when administered alone or as triple therapy.
(5) Pharmacokinetics at concomitant administration of vonoprazan, low-dose aspirin or vonoprazan, NSAIDs: The drug interaction study in healthy adult male subjects administered with vonoprazan 40 mg and aspirin 100 mg or NSAID (loxoprofen sodium 60 mg, diclofenec sodium 25 mg or meloxicam 10 mg) concomitantly showed no clear effect of low-dose aspirin or NSAIDs on pharmacokinetics of vonoprazan and of vonoprazan on pharmacokinetics of low-dose aspirin or NSAIDs.

Gastric ulcer, duodenal ulcer, reflux esophagitis, prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration, or prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration.
Adjunct to Helicobacter pylori eradication.
Precautions for INDICATIONS: Prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration: This drug should be administered to the patients who are under continuous administration of low-dose aspirin for prevention of blood clots and emboli formation. History of gastric ulcer or duodenal ulcer should be confirmed before starting administration.
Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration: This drug should be administered to the patients who are under continuous administration of NSAIDs for purpose such as pain management of rheumatoid arthritis or osteoarthritis, etc. History of gastric ulcer or duodenal ulcer should be confirmed before starting administration.

Gastric ulcer, duodenal ulcer: Usually, for adults, a daily oral dose of 20 mg of vonoprazan is administered once a day. For the treatment of gastric ulcer, the usual administration should be limited up to 8 weeks, and for duodenal ulcer, up to 6 weeks.
Reflux esophagitis: Usually, for adults, a daily oral dose of 20 mg of vonoprazan is administered once a day. The usual administration should be limited up to 4 weeks. However, when the effect is insufficient, the drug may be administered up to 8 weeks. In addition, for the maintenance of healing of reflux esophagitis to prevent recurrence or relapse of the condition, a daily oral dose of 10 mg is administered once a day until 24 weeks.
Prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration: Usually, for adults, a daily oral dose of 10 mg of vonoprazan is administered once a day.
Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration: Usually, for adults, a daily oral dose of 10 mg of vonoprazan is administered once a day.
Adjunct to Helicobacter pylori eradication: Usually, for adults, the following 3 drugs are orally administered at the same time twice daily for 7 days: 20 mg/dose of vonoprazan, amoxicillin hydrate, and clarithromycin.
When Helicobacter pylori eradication treatment with 3 drugs consist of a proton pump inhibitor, amoxicillin hydrate, and clarithromycin fails, alternative treatment with the following 3 drugs is given; usually, for adults, 20 mg/dose of vonoprazan, amoxicillin hydrate, and metronidazole are orally administered at the same time twice daily for 7 days. The doses of antibiotics should follow the latest National Consensus on Management of Dyspepsia & Helicobacter pylori infection recommendations for Helicobacter pylori infections.
Careful Administration: VOCINTI Tablets should be administered with care in the following patients:
(1) Patients with hepatic disorders [A delay in the metabolism and excretion of VOCINTI Tablets may occur, which may result in an increase in the concentration of vonoprazan in blood.]
(2) Patients with renal disorders [A delay in the excretion of VOCINTI Tablets may occur, which may result in an increase in the concentration of vonoprazan in blood.]
(3) Elderly patients.
Special Patient Populations: Elderly Patients: Since the physiological functions such as hepatic or renal function are decreased in elderly patients in general, vonoprazan should be carefully administered.
Pediatric Use: Vonoprazan has not been studied in patients under 18 years of age.
Impaired Renal Function: Vonoprazan should be administered with care in patients with renal disorders as a delay in the excretion of vonoprazan may occur, which may result in an increase in the concentration of vonoprazan in the blood.
Impaired Hepatic Function: Vonoprazan should be administered with care in patients with hepatic disorders as a delay in the metabolism and excretion of vonoprazan may occur, which may result in an increase in the concentration of vonoprazan in the blood.

There is no experience of overdose with vonoprazan.
Vonoprazan is not removed from the circulation by hemodialysis. If overdose occurs, treatment should be symptomatic and supportive.

VOCINTI Tablets are contraindicated in the following patients:
[1] Patients with a history of hypersensitivity to any of the ingredients of this drug.
[2] Patients who are receiving atazanavir sulfate or rilpivirine hydrochloride (see Interactions).

Important Precautions: At the treatment, the course of the disease should closely be observed and the minimum therapeutic necessity should be used according to the disease condition.
In the long-term treatment with VOCINTI Tablets, close observation by such means as endoscopy should be made.
In the maintenance of healing of reflux esophagitis, VOCINTI Tablets should be administered only to the patients who repeat recurrence and recrudescence of the condition. Administration to the patients who do not necessitate maintenance of healing should be avoided.
Hepatotoxicity: Hepatic function abnormalities including liver injury have been reported in clinical studies. Post marketing reports have also been received in patients treated with vonoprazan, many of which occurred shortly after initiation of treatment. Discontinuation of vonoprazan is recommended in patients who have evidence of liver function abnormalities or if they develop signs or symptoms suggestive of liver dysfunction.
Elevation of intragastric pH: Administration of vonoprazan results in elevation of intragastric pH and is therefore not recommended to be taken with drugs for which absorption is dependent on acidic intragastric pH (see Interactions).
Masking of Symptoms Associated with Gastric Malignancy: Gastric malignancy may present with symptoms associated with acid-related disorders which initially respond to drugs that elevate intragastric pH. A symptomatic response to vonoprazan does not exclude the presence of gastric malignancy.
Clostridium difficile Serious colitis, including pseudomembranous colitis: There is an increased risk of gastrointestinal infection caused by Clostridium difficile as was reported in patients that received proton pump inhibitors. Drugs that elevate intragastric pH may be associated with an increased risk of Clostridium difficile gastrointestinal infection. Serious colitis accompanied with bloody stools, such as Pseudomembranous colitis, may occur due to amoxicillin hydrate or clarithromycin being used for Helicobacter pylori eradication, in combination with vonoprazan. If abdominal pain and frequent diarrhea occur, appropriate measures, such as immediate discontinuation of the treatment, should be taken.
Benign gastric polyps: Benign gastric polyps has been observed in patient on long-term administration of PPIs.
Bone Fractures: An increased risk for osteoporosis-related fractures of the hip, wrist or spine, predominantly in the elderly or in presence of other recognized risk factors, has been reported in patients under treatment with proton pump inhibitors. The risk of fracture was especially increased in the patients receiving high dose or long term (a year or longer) treatment.
Precautions concerning Use: When dispensing the drug: The patient must be instructed to remove the tablets from the press-through package (PTP) before they are ingested. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, and this could result in serious complications such as mediastinitis.]
Other Precautions: (1) In 2-year carcinogenicity studies in mice and rats, following observations were made: neuroendocrine tumors in the stomach with the similar exposure (AUC) at the clinical dose (20 mg/day) of vonoprazan, adenoma in the stomach (mouse) at the exposure approximately 300 times of the clinical exposure, and hepatic tumor at approximately more than 13 times (mouse) and approximately more than 58 times (rat) of the clinical exposure.
Drug abuse and dependence: Vonoprazan has no known potential for abuse or dependence.
Effects on ability to drive and use machines: The influence of vonoprazan on the ability to drive or use machines is unknown.

Pregnancy: No clinical studies have been conducted to date to evaluate vonoprazan in subjects who are pregnant. In a rat toxicology study, embryo-foetal toxicity was observed following exposure of more than approximately 28 times of the exposure (AUC) at the maximum clinical dose (40 mg/day) of vonoprazan.
As a precaution, vonoprazan should not be administered to women who are or may be pregnant, unless the expected therapeutic benefit is thought to outweigh any possible risk.
Lactation: No clinical studies have been conducted to date to evaluate vonoprazan in subjects who are lactating. It is unknown whether vonoprazan is excreted in human milk. In animal studies it has been shown that vonoprazan was excreted in milk. During treatment with vonoprazan, nursing should be avoided if the administration of this drug is necessary for the mother.

The following convention is used for the classification of the frequency of an adverse drug reaction (ADR) and is based on the Council for International Organizations of Medical Sciences (CIOMS) guidelines: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Clinical Trials: Clinical trial data for expected adverse events is based on pooled safety analysis from the following studies: EE healing (CCT-001 and CCT-002), EE maintenance therapy (CCT-003 and OCT-001), GU healing (CCT-101), DU healing (CCT-102), prevention of recurrence of peptic ulcer associated with NSAID use (CCT-301, OCT-301 and OCT-303) and prevention of recurrence of peptic ulcer associated with LDA use (CCT-302, OCT-302 and OCT-304). (See Table 15.)


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Postmarketing: Following is a list of ADRs which have been observed in postmarketing and are not included previously: See Table 16.


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Administration of vonoprazan results in elevation of intragastric pH, suggesting that it may interfere with the absorption of drugs where gastric pH is an important determinant of oral bioavailability. Use of vonoprazan is therefore not recommended with some of these drugs for which absorption is dependent on acidic intragastric pH such as atazanavir and nelfinavir, due to significant reduction in their bioavailability.
VOCINTI Tablets are metabolized mainly by hepatic drug-metabolizing enzyme CYP3A4 and partially by CYP2B6, CYP2C19 and CYP2D6.
Gastric antisecretory effect of VOCINTI Tablets may promote or inhibit absorption of concomitant drugs. Use of vonoprazan is therefore not recommended with some of these drugs for which absorption is dependent on acidic intragastric pH. (See Tables 17 and 18.)


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Store below 30°C.
Shelf life: 36 months.

Antacids, Antireflux Agents & Antiulcerants

A02BC08 - vonoprazan ; Belongs to the class of potassium-competitive acid blocker. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

K